Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl sailcylate 0.060%
THYMOL 0.064%
Antiseptic Mouth Rinse
FDA Label NDC 42507-210
14 label sections · Submitted to the FDA by Hy-vee, Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hy-vee, Inc for the product Antiseptic Mouth Rinse (NDC 42507-210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis
Use
helps control plaque that leads to gingivitis
Warnings
for this product
Do Not Use
if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease
Stop Use And Ask A Dentist If
gingivitis, bleeding, or redness persists for more than 2 weeks
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Directions
adults and children 12 years
of age and older - vigorously swish20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children under 12 years of age - consult a dentist or doctor
• this rinse is not intended to replace brushing or flossing
Other Information
cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰- 77⁰F)
Inactive Ingredients
water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40
Disclaimer
This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine
Adverse Reaction
DISTRIBUTED BY HY-VEE, INC
5820 WESTOWN PARKWAY
WEST DES MOINES, IA 50266
SATISFACTION GUARANTEED
OR PURCHASE PRICE REFUNDED
FOR INFORMATON CALL
1-800-289-8343
www.hy-vee.com
Claims
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
Principal Display Panel
Compare to active ingredients
in Citrus Advanced Listerine
with Tartar Protection
Tartar Control
Antiseptic
Mouth Rinse
Citrus
•Helps fight tartar buildup
•Fights plaque + gingivitis
•Kills germs for extended plaque protection
•Enhanced breath protection
1.5 LITERS (50.7 FL OZ)
Image Description (Mm1)
* Please review the disclaimer below.
